Is "Sputnik" vaccine our answer to coronavirus or is it the Russian roulette?

Is "Sputnik" vaccine our answer to coronavirus or is it the Russian roulette?

20 August , 15:54Science
The Sputnik V coronavirus vaccine is registered in Russia. However, the Association of Pharmaceutical Manufacturers asked the Ministry of Health to postpone the registration of the vaccine, since the drug did not pass full tests.

However, federal authorities are talking about the mass vaccinations against coronavirus this fall.

Irina Mishina

The coronavirus vaccine, dubbed Sputnik V, was registered on 11 August. However, the registration is "temporary". According to the creator of the vaccine Denis Logunov, the drug was created in just two weeks.

Под руководством Дениса Логунова отечественная вакцина от коронавируса была создана всего за 2 недели.

In general, making a vaccine is a long and painstaking business. Typically, the full cycle of development and release of new vaccines can take 10-15 years. But according to the employees of the National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya of the Ministry of Health of Russia, they "were based on previous developments".

One of the president's daughters has already tried the vaccine. According to him, after the first vaccination, her temperature rose to 38, the next day - 37 with a little, then everything went away. “After the second injection, the second vaccination, the temperature also rose a little, but then it subsided. Feels good, and high titers", - said the Russian president at a meeting with members of the government on August, 11.

After such advertising, everyone, apparently, had to believe in the miraculous properties of the new Russian vaccine against coronavirus. Judging by the name, it is designed to become a medical analogue of the first Soviet space satellite, ahead of the whole world and showing him "Kuz'ka's mother". But experts suddenly began to doubt. Moreover, the further - the more.

“In my opinion, it is symbolic that the Russian vaccine against coronavirus was named Sputnik. This is a metaphor. But will it not happen that the engine and basic mechanisms of this "satellite" were checked, but they did not find out whether it could fly. I am not saying this for a "catchphrase". It's just that I'm aware of how this vaccine was prepared. To date, the third phase of trials of this vaccine has not been completed; it is being carried out on a fairly limited number of people. And in general, as far as I know, the vaccine has not been finalized, its delayed action has not been clarified. If an incompletely tested vaccine is given to a person, he may develop a false sense of security. In general, with the transparency of research on this vaccine, everything is very vague. In general, there are big problems with evidence-based medicine in Russia. In my opinion, registration of the Sputnik vaccine is something on the brink of risk", - Olga Matveyeva, a senior researcher at the University of Utah (USA), a molecular biology specialist, told NI.

The main thing that many scientists from different countries agree on is the disadvantages of the third phase of testing the Russian Sputnik. This phase of vaccine research usually occurs on tens of thousands of volunteers. So far, our third stage includes tests on 2 thousand volunteers. From the point of view of international practice, this is very little.

Ilya Yasny, head of the scientific expertise of Inbio Ventures, has a negative attitude to the registration of a vaccine that has not passed all stages of testing. “This is contrary to all norms of vaccine and drug development - scientific, ethical, or whatever. In the West, according to the results of the first phase of the study, at least press releases were published, many even published articles where there is a similar analysis of what happened, and now they are starting to study the third phase, in which up to 30 thousand people are involved. what is the comparison with what has been done at the Gamaleya Institute”, - the expert said.

Руководитель ФБГУ НИЦЭМ им.Гамалеи Минздрава России Александр Гинцбург сообщил о том, что западные ученые "пытаются переманить" в свои институты сотрудников его учреждения.

The members of the Association of Clinical Research Organizations (AOKI), which includes leading pharmaceutical companies, share the same opinion. AOKI appealed to the Ministry of Health of the Russian Federation with a request to postpone the registration of the Russian vaccine against COVID-19. In her address, the race for the vaccine was called "a relic of the heroic paradigm".

But perhaps we are simply envied by foreign microbiologists whom Russian scientists have managed to outstrip? Director of the National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya Alexander Gintsburg has already circulated a statement that Western scientists "are trying to lure employees of the National Research Center (SIC) of the National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya of the Ministry of Health of the Russian Federation into their institutes, but this is useless". "I would not call it a conspiracy. I would say that this is a natural reaction of Western companies, negative to the unexpected appearance of a domestic product. Therefore, I think we need to withstand this negativism, which has now fallen upon us and which is well paid", - Alexander Gintsburg emphasized.

You can, of course, ignore the opinion of Western scientists. But what to do with the opinion of our, domestic? Most physicians interviewed by the Doctor's Handbook said they were not ready to receive the coronavirus vaccine created at the National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya. Out of more than 3 thousand respondents, 52% answered negatively to this question. 66% of those surveyed said that there is insufficient data on the effectiveness of this vaccine. 48% were confused by the fact that it was possible to create the tool in too short a time. It is hard to believe that the opinion of more than three thousand specialists was "paid for" by someone. Only 20% of those surveyed said they would recommend vaccination to patients, colleagues or friends. The survey was conducted on August 12-13 through the profile application "Doctor's Handbook". 3040 medical specialists took part in it.

And nevertheless, teachers and doctors will be vaccinated with the "temporarily registered" Russian vaccine in the near future. If the federal authorities decide to start mass vaccination against coronavirus this fall, teachers and doctors will actually become an experimental group to test a new vaccine. The Interregional Trade Union of Educators "Uchitel" has published an Appeal to the Government of Russia. It states that vaccination must be voluntary until all stages of the trial are completed. “Pressure is likely to be exerted on principals of schools and other institutions to convince (read:“ find ways to get ”) all workers to get vaccinated”, - the Appeal says. That is, teachers and health workers can actually become material for the 3rd phase of testing the coronavirus vaccine, which in Russia was carried out hastily and opaquely, on a small number of people.

“We are told: “You have the right not to be vaccinated”. Yes, formally there can be a withdrawal from vaccination for health reasons. But this will automatically turn into a denial to work. There is already an example: Yelena Rangailo, a teacher at the Academy of Urban Environment, Construction and Printing of St. Petersburg, who refused from one vaccination, I was able to recover at work only through the court. Many are simply dangerous for health reasons. For example, because of my age, I approach this with caution", - said Marina Balueva, co-chairman of the Uchitel interregional trade union, to NI. that before vaccination, a person must be carefully examined, taking into account his state of health. But we have a continuous rush and race. Nobody takes into account that the vaccine can have long-term consequences. The vaccine is actually tested on humans", - Marina Baluyeva told NI.

The reason for the rush to vaccinate is not only the health of compatriots, but also the economy. The coronavirus hasn't gone anywhere. In the world of COVID-19, almost 20 million people have already been ill, of which 730 thousand people have died. Some scientists believe that a second and even a third wave of the virus will begin in the near future. In addition to harm to health, the pandemic is causing serious damage to the economies of many countries. According to IMF forecasts, for the whole of 2020, the American economy will lose 8%, the EU economy - 10%, and the Russian economy - 6.6%. To stop the pandemic, 60-70% of the population must become immune to the virus.

According to scientists, today the global need for vaccines against coronavirus exceeds 3-5 billion doses. In money it is more than $ 75 billion. Russian developers plan to compete for a quarter of this amount. By the end of 2021, they are going to supply 1 billion doses to the world market. The creation of the Russian vaccine is financed by RDIF - Russian Direct Investment Fund - a sovereign investment fund of the Russian Federation, created by the Russian government in 2011 to invest in leading companies in fast-growing sectors of the economy. It was RDIF that invested in the fight against coronavirus. This fund manages investment assets of $ 10 billion. 4 billion rubles were allocated for the production of the vaccine. Funds for the development of a vaccine against the coronavirus of the National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya was also allocated by Sberbank (50 million rubles went to the creation of a project office). The vaccine is also financed through the Ministry of Health.

Why was the choice stopped at the Gamaleya Institute?

“We analyzed all the world's vaccine developments and made a bet on the Gamaleya Institute's drug, which turned out to be the best. Russia has a scientific advantage over other countries [and ahead of them - editor's note] from six months to a year", - said Kirill Dmitriyev, head of RDIF. Here is how he sees the main advantages of the Russian vaccine: “Firstly, it is based on the six-year experience of the N.F. Gamaleya on Ebola vaccine and MERS. The new vaccine is made on an adenovirus platform. That is, a light human cold virus is taken as a basis, which does not multiply in the body, but delivers a specially built-in gene (spike protein) of the coronavirus to stimulate the immune response".

The head of the RDIF outlined rather schematically the advantages of the Gamaleya Institute's developments. If you look in more detail, not everything is so rosy and optimistic about these achievements. This was repeatedly reported in their investigations by journalists close to medical circles.

Vaccine development Gamalei has been studying for a long time. But not to say too successful. In 2009, RUSNANO signed a contract for the production of three drugs, including the influenza vaccine AdeVac-Fleu. An application for financing the project, estimated at 1.6 billion rubles, was submitted by the National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya. According to Fontanka, a little-known company NTFarma was chosen as a party to the contract, and the Research Institute of Gamaleya retained the role of co-executor and curator of the scientific program. 11 years later, in January 2020, the project ended with the verdict of the Khoroshevsky District Court of Moscow on the theft of more than 400 million rubles from the Rusnano corporation. The corporation got the foundation of a pharmaceutical enterprise near Yaroslavl from the project and drugs that did not pass registration. The vaccine "AdeVac-Flu" has been undergoing clinical trials since 2015 and has not yet been registered.

The second attempt to create an anti-influenza vaccine, scientists of the National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya were undertaken in mid-2010. However, the GamFluVac preparation never entered the domestic and world markets. The Ministry of Health has no reason to consider it safe yet, it does not register a vaccine. Clinical trials have been going on for two years.

The third attempt to develop a vaccine based on the "vector method" Institute of Gamaleya took over in 2014 when the Ebola epidemic broke out in Africa. In February 2016, Vladimir Putin announced the registration of a Russian drug for this dangerous virus. The message made a lot of noise: before that, no one could develop such a vaccine. But the enthusiasm was soon replaced by a modest silence: the documents about the clinical trials were never received by the WHO. Preparations from the National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya were not allowed to vaccinate the population during the new outbreaks of the epidemic in Africa. They are still undergoing international clinical trials with no apparent hope of recognition. The result: the Russian vaccine was injected into 2 thousand Guinean volunteers, and Academician Gintsburg was awarded the Order of Merit of the Republic of Guinea for his outstanding contribution to the fight against the epidemic.

The fourth attempt by scientists at the Gamaleya Institute to introduce something into pharmaceuticals was work on a vaccine against the Middle East respiratory syndrome (MERS-CoV, or MERS-cov). The result: the vaccine has not been registered by the Ministry of Health, it is not known to the world scientific community.

And finally, the fifth attempt: the coronavirus vaccine. The state task for the creation of a vaccine against COVID-19 was issued by the Ministry of Health to the Gamaleya Institute April 20, 2020. A month later, the director of the institute, Alexander Gintsburg, announced the readiness of the drug and said that it had been tested on employees. In an interview with Meduza, the creator of the vaccine, Denis Logunov, spoke about the two-week development period and confirmed that the Gam-Covid-Vac vaccine is a copy-paste of the MERS-GamVac vaccine against Middle East respiratory syndrome. They differ only in the type of virus protein. Head of the National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya Alexander Gintsburg also keeps repeating that the coronavirus vaccine is the fruit of the Institute's work on previous drugs (these results, as you know, in some cases did not lead to mass vaccination, in other cases they did not reach registration at all). Nevertheless, at the April meeting with Vladimir Putin, Alexander Gintsburg, referring to the previous merits of his institution, asked for 1.5 billion rubles. for bottling vaccines on the premises of the Institute. Gamalei.

As for the "achievements" of the Gamaleya Institute, in fairness it should be noted that it still has one indisputable achievement - the BCG vaccine introduced into life. All this data can be easily found in the public domain.

Добровольцы, на которых испытывали новую российскую вакцину против коронавируса, выписаны. Фото на память.

When creating a Russian vaccine against coronavirus, the Ministry of Health turned a blind eye to many things. For example, the fact that the Gamaleya Institute tested the drug on their employees, and this is contrary to federal law: without special permission, tests on a person cannot be carried out. Such permission, however, was issued retroactively - only on June 16. This is also outside the scope of the World Medical Association's Declaration of Helsinki, the compliance with which is prescribed in the study protocol. Military personnel also fall under the protection of the declaration. However, they are also among the volunteers on whom the vaccine is being tested. In general, in world practice, it is not customary to involve physicians and the military in testing medicines and vaccines. The reason is simple: both are considered “vulnerable research subjects”: those who are higher in the hierarchy can put pressure on them.

But that's not all. Neither the observation diaries of the volunteers nor the survey data of the group of subjects have been made public...

However, the Gamaleya Institute finds an explanation for this. “Nobody really published the volunteers' diary. After the introduction of the vaccine, they had common symptoms: many had a fever for several hours, some did not feel well for a long time",- the professor of virology at the National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya Anatoly Alshtein explained to NI.

Ни один из добровольцев , принявших участие в испытании новой российской вакцины, не поделился своими впечатлениями.

We asked what the uniqueness of the Russian vaccine is and how it actually differs from the coronavirus vaccines that are being developed in other countries. “This vaccine is based on adenovirus. It is directed against the SARS COV-2 coronavirus. This vaccine contains the coronavirus gene. The particles of adenovirus contain the genomes of the coronavirus. This fragment is responsible for the formation of a protein that is necessary for the development of immunity against the coronavirus, ”explained Professor Alstein.

Well, what will happen if the coronavirus begins to mutate? After all, many experts are talking about this, dozens of press conferences are dedicated to this... “This vaccine is designed against one type of coronavirus. If other types of coronavirus appear, another vaccine will be needed, ”Prof. Alstein said.

And, finally, the main thing: why in the Gamaleya Institute there is virtually no data on the third phase of vaccine trials. The professor's answer came as a surprise. “There are no such in-depth vaccine trials. This is not a medicine. The vaccine is different. The vaccine is administered 1-2 times, this gives immunity and protection for a year or two. The purpose of this vaccine is to create herd immunity. After that, the wave of the epidemic should decline”, - assured Professor of the Gamaleya Institute Anatoly Alshtein.

However, scientists have questions about this approach to vaccine development.

“The Russian vaccine against coronavirus has been registered temporarily. And this is no coincidence, - says Olga Matveyeva , senior researcher at the University of Utah (USA), specialist in molecular biology. - The fact is that it has not been fully tested and finalized. We are assured that it was tested on monkeys and did not cause any negative reaction in animals. But in order to understand this, it is necessary to conduct tests on thousands of monkeys. Where can I get them in Moscow? It is quite difficult and costly. Most likely, 10-15 animals were used. But that doesn't give any picture. Also, the Gamaleya Institute does not disclose the principle of a vaccine, but in vain. She is "vector". What does it mean? Vectors from different viruses must deliver the antigen for the immune system to learn to recognize the source of infection. Adenovirus-5 and adenovirus-26 are used as such “vectors” in the vaccine. But the fact is that "adenovirus-5" is quite widespread, and its body can begin to reject, that is, the vaccine either does not work or does not give the expected result. A second injection will be needed, where a rather rare "adenovirus-26" is used, and here antibodies can begin to form. So the very principle of a vaccine raises many questions”, - says a senior researcher at the University of Utah (USA).

With regard to the phases of vaccine trials, there are even more questions. Vaccination, as we are told, will be massive, which means that it will affect different groups of the population, people of different ages, with different weights, prone to various diseases. “In immunology, it is important to go through 3 phases of testing. All Western scientific laboratories publish detailed reports on the progress of each phase of vaccine trials. We have solid secrets, - microbiologist Vyacheslav Zaitsev-Friedshtand told NI. - In Russia, nothing is published on either the first, or the second, or the third phase of vaccine trials. Let's say the vaccine was tested on volunteers. But we do not see in the reports whether they are the same people or different, what their age, weight, height, whether they are healthy or prone to some kind of disease... On the TV screen we saw only male volunteers of the same age. But the vaccine is tested on different groups - on women, men, and of different ages, on elderly people (there is practically no word about this at all). We do not know whether the vaccine was tested, for example, in people prone to hypertension, in people with other chronic diseases, whether people from the so-called risk group were included in the number of subjects. The Gamaleya Institute has not released any clinical studies. The most important, the third phase of testing, should extend to tens of thousands of people. Well-known laboratories involve more than 30 thousand people in it. In our country, it is reported that about 2 thousand volunteers will take part in the third phase trials. From the point of view of international practice, this is very little. And this hardly gives an idea of the effectiveness of the vaccine. Also, when vaccinating, the dosage is very important. That is, how much substance should be injected to people of different weights and different ages. There is silence again. In the United States, as far as I know, a vaccine is approved and officially registered only if its effectiveness is at least 50 percent. And what is the effectiveness of our "Sputnik"? Nobody talks about it", - microbiologist Veniamin Zaitsev-Friedshtand told NI.

“According to the results of the first phase of the study, all leading vaccine developers in the West published at least press releases, many have already published articles where there is a similar analysis of what happened, and now they are starting the third phase of research. This cannot be compared with what has been done at the Gamaleya Institute”, - says Ilya Yasny, the head of the scientific expertise of Inbio Ventures.

Making a vaccine is a long and painstaking business. In normal times, the full cycle of development and release of new vaccines can take 10-15 years. As always, we decided to be "ahead of the rest" and made the vaccine in 2 weeks. But the health of thousands of people is not a "five-year plan in 4 years." For some, this vaccine may not be beneficial, but harm, for someone it can cause an unpredictable side effect, moreover, delayed in time.

What do scientists suggest? First of all, to conduct the 3rd phase of testing according to generally accepted world standards on tens of thousands of people of different categories and groups. Next - publish this data. In fact, we are not talking about cosmic secrets, but about the life and health of people!

There is one more point of view in the scientific community. Instead of investing in the production of its own "raw" development, Russia could spend money on the purchase of vaccines, far ahead of it in terms of research stages. These include the Oxford vaccine, the drugs created by Johnson and Johnson, and some others. But only after waiting for the publication of their tests - after all, these drugs may well turn out to be ineffective.

“At the Gamaleya Institute and in other places there are many people who are sure that they are ahead of the rest of the world, they are not ordered by Western instructions and rules, and they will work the same way as their teachers did 50 years ago. This is an extremely vicious practice It must be admitted that Russia is very far behind the rest of the world in the field of medicine, and it is necessary at least to start doing what, say, in Western Europe. But, unfortunately, the dominant practice is personal experience and protrusion "Plus political pressure: to make the vaccine the first in the world", - said the expert Ilya Yasny.

By the way, there has already been a response to the Russian vaccine from the World Health Organization. The WHO said that the Russian vaccine will receive the status of "prequalified" WHO only after a thorough study of the data on its safety and effectiveness.

In general, this whole story with the temporary and hasty registration of the coronavirus vaccine resembles some kind of strange experiment. The vaccine may be effective and safe, but it may also be the other way around. The shot can be blank, or it can be deadly. I would like to hope that the cautious attitude of experts and international institutions to its release will nevertheless force the domestic creators of the vaccine to test the vaccine so that it does not turn into a “Russian Roulette”.

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